Top-Notch, Practical Solutions

When it comes to records and document policies, procedures and controls, Cerulean goes beyond “best practices” to practicalities and realistic solutions. Our managing director spent his career putting in place records management departments, IT departments and ensuring compliance with 21 CFR Part 11 and EU Annex 11. Today, John Avellanet helps clients solve their records retention problems and regulatory records worries.

“Cerulean was able to take the bare bones of a document retention need, and actually apply the FDA regulations, the EMA rules, the state statutes, and the ISO guidelines to the daily realities of our business. With John’s help, we were able to develop a top-notch records retention policy and matrix that actually sticks, providing needed benefits for years to come.

Mr. Avellanet has extensive knowledge not only of the applicable laws and regulations and document retention best practices, he also has a depth of knowledge with respect to the various IT systems impacted by the implementation of records retention efforts. He was therefore invaluable in coordinating between the various stakeholders in the project.

I could not have been happier with Cerulean’s work product, professionalism, and positive attitude throughout the project.

Client Success Story

John Avellanet provides excellent advice that is both compliant and reasonable. He also works within the constraints of a company’s business realities when providing advice. This has helped integrate the controls into our company much faster and for a lot less; with our small staff and low budget, this has been extremely helpful. I would recommend Cerulean for small to mid-size firms that need to be in regulatory compliance with the FDA and want to get to market (or partnership) quickly.